Director Biotransformation and Drug-Drug Interaction
Disc Medicine
Careers
Director Biotransformation and Drug-Drug Interaction
COMPANY OVERVIEW:
Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.
POSITION OVERVIEW:
Disc Medicine has a new role as Director, Biotransformation and Drug-Drug interaction (DDI) area. The successful candidate will provide biotransformation and DDI evaluation strategy and execution to support drug discovery and clinical development. This includes designing in vitro metabolic enzyme and transporter-related studies, drug-drug interaction risk evaluation, and clinical DDI evaluations via clinical studies and/or PBPK modeling. This person is expected to interact with cross-functional teams providing biotransformation, DDI evaluation, and other scientific inputs. The successful candidate will also provide biotransformation-related strategy and support to achieve program milestones, including IND, IB, and NDA submissions. The candidate should have expertise in drug metabolism, transporter, and drug-drug interaction areas with comprehensive knowledge of best regulatory practices and experimental methodology.
RESPONSIBILITIES:
- Provide biotransformation and DDI evaluation to enable internal decisions and regulatory filings.
- Manage outsourced biotransformation and DDI work to ensure high-quality deliverables of in vitro and in vivo studies.
- Represent Disc Medicine at regulatory meetings and respond to regulatory inquiries related to biotransformation and DDI.
- Provide biotransformation and DDI support for regulatory summary documents.
REQUIREMENTS:
- Ph.D. with > 8 years of experience in drug metabolism, biotransformation, and DDI evaluation in the pharmaceutical industry.
- Strong understanding of drug metabolism and transporter concepts, familiar with FDA’s guidance on DDI evaluations, and comprehensive knowledge of quantitative DDI risk assessment.
- Excellent interpersonal, organizational, and communication skills. Experience in cross-functional interactions in matrix teams.
- Experience in writing and presenting biotransformation and DDI results to regulatory authorities in supporting IND to NDA/MAA applications.
- Track record of scientific excellence in biotransformation and DDI assessment, evidenced by publication in scientific journals and/or presentation at scientific conferences.
PREFERRED QUALIFICATIONS:
- Broad experience in small molecule drug development supporting early- and late-stage drug discovery and development.
- Experience in working with CROs.
- Using SimCYP in DDI evaluations.
- Design and execution of isotope-ADME studies in animals and humans.
Disc Medicine is an equal opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment.
Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to our Human Resources Department at careers@discmedicine.com and include the title of the position you are applying for in the subject line. Applications may also be submitted via LinkedIn.
Please note that agency phone calls or submissions will not be accepted.
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